FDA 510(k)

Conformity Stem

K-Number: K183312 · 2019-08-08

Decision Date2019-08-08

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Conformity Stem is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2019-08-08 under approval number K183312. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Conformity Stem?

Conformity Stem is a medical device that received FDA 510(k) clearance on 2019-08-08. It is manufactured by United Orthopedic Corporation. The 510(k) number is K183312.

When was Conformity Stem approved by the FDA?

Conformity Stem received FDA 510(k) clearance on 2019-08-08, under approval number K183312.

What company makes Conformity Stem?

Conformity Stem is manufactured by United Orthopedic Corporation.

What is the FDA product code for Conformity Stem?

The FDA product code for Conformity Stem is LZO.

Other Devices by United Orthopedic Corporation

K152430All Poly Tibial Component K152439U2 Bipolar Implant and 22mm Femoral Head K152530UCP Stem K172251UTS Stem K170089U-Motion II Acetabular System Additional sizes K163441Locking Cage, Full XPE Cup

View all 26 devices →

Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.